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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015083
Receipt No. R000017549
Scientific Title Effect of ingested water volume on the pharmacokinetics of acidic or basic drugs after administered as orally disintegrating tablets
Date of disclosure of the study information 2014/09/08
Last modified on 2021/03/15

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Basic information
Public title Effect of ingested water volume on the pharmacokinetics of acidic or basic drugs after administered as orally disintegrating tablets
Acronym Effect of ingested water volume on the pharmacokinetics of drugs
Scientific Title Effect of ingested water volume on the pharmacokinetics of acidic or basic drugs after administered as orally disintegrating tablets
Scientific Title:Acronym Effect of ingested water volume on the pharmacokinetics of drugs
Region
Japan

Condition
Condition digestive disorder
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main purpose of this study is to make clear the impact of water volume ingested with medicine on the absorption and pharmacokinetic of orally administered drugs. Three kinds of orally disintegrating tablets including acidic, basic and enteric coated drugs are administered with or without water and the blood concentration profile of each drug will be compared.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Blood concentration profile of each drug after oral administration with or without water ingestion.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Number of subjects : 12
Period of study: 2 days
1) Volunteers are fasted overnight.
2) Volunteers are administered three kinds of drugs (Pitavastatin calcium, Glimepiride, Lansoprazole) orally as OD tablets with water ingestion and then blood is sampled periodically.
Interventions/Control_2 Number of subjects : 12
Period of study: 2 days
1) Volunteers are fasted overnight.
2) Volunteers are administered three kinds of drugs (Pitavastatin calcium, Glimepiride, Lansoprazole) orally as OD tablets without water ingestion and then blood is sampled periodically.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
40 years-old >
Gender Male
Key inclusion criteria 1) Men, Japanese,
If students, this volunteer shop does not affect the required course in their University.
2) BMI is 18.5>= and <25.0.
Key exclusion criteria 1)Who having (or had) a medical history of circulatory system disease, hepatic disease, renal disease, digestive system disease, hematological disorder.
2)Who taking a medicine that night affect the study result.
3)Who judged as inappropriate to this study by the primary doctor of this study from diagnosis, vital signs, inductive electrocardiograph, hematological assessment, blood biochemical test, urinary test, immunological test.
4)Who took a medicine within 7 days before the study
5)Who participated in the clinical trail and took a test medicine within 3 months before the study.
6)Who having (or had) an allergic constitution to medicine/food
7)Who having (or had) a dependency to drug or alcohol
8)Who judged as inappropriate to this study by the primary doctor due to any other reasons
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Yamashita
Organization Setsunan University
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 45-1, Nagaotoge-cho, Hirakata, Osaka, Japan
TEL 072-866-3125
Email shinji@pharm.setsunan.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Yamashita
Organization Setsunan University
Division name Faculty of Pharmaceutical Sciences
Zip code
Address 45-1, Nagaotoge-cho, Hirakata, Osaka, Japan
TEL 072-866-3125
Homepage URL
Email shinji@pharm.setsunan.ac.jp

Sponsor
Institute Faculty of Pharmaceutical Sciences, Setsunan University
Institute
Department

Funding Source
Organization Towa Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Towa Pharmaceutical Co. Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人相生会 博多クリニック(福岡県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 09 Month 03 Day
Date of IRB
2014 Year 09 Month 08 Day
Anticipated trial start date
2014 Year 09 Month 19 Day
Last follow-up date
2021 Year 03 Month 15 Day
Date of closure to data entry
2021 Year 03 Month 15 Day
Date trial data considered complete
2021 Year 03 Month 15 Day
Date analysis concluded
2021 Year 03 Month 15 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 08 Day
Last modified on
2021 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017549

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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